A First Time in Human Study to Evaluate the Safety and Tolerability of GSK4381406 in Healthy Participants

Summary

This is a 3-part First Time in Human (FTIH) study to evaluate the safety, tolerability, and pharmacokinetics (PK) profile of GSK4381406 following administration of single ascending doses (Part 1), repeat ascending doses (Part 2), and repeat doses with an indomethacin challenge (Part 3) in healthy adult participants. Part 1 consists of 4 planned cohorts with up to 2 treatment periods in each and is expected to have 6 doses (but can accommodate up to 7 doses). The impact of food on PK of GSK4381406 will also be assessed. Part 2 will investigate 14 days of repeat dosing in 3 cohorts with 3 dose levels. Part 3 will evaluate the impact of repeat doses of GSK4381406 versus placebo on indomethacin induced changes in small intestinal permeability in healthy participants.

Timeline

Start

2023-10-31

Primary completion

2024-12-05

Completion

2024-12-05

Outcome

Outcome not reported

Stopped (Business): “Study terminated prior to FSFV for strategic business reasons.”

Drugs

Indications